Paragraph IV (Patent) Challenges for GILOTRIF

Non-Orange Book US Patents for GILOTRIF

For Orange Book-listed
patents (shown in the main table above) generic applications
must certify that the listed patents are expired, invalid, or
will not be infringed by generic entry.

The non-Orange Book patents listed
below do not require formal certifications, so they do not
automatically impede generic entry. Instead, they represent
potential opportunities for branded firms to block generic
entry through patent infringment challenges.

PRODUCT NAME: AFATINIB, THE TAUTOMERS, THE STEREOISOMERS AND THE SALTS THEREOF, OPTIONALLY IN THE FORM OF PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF WITH INORGANIC OR ORGANIC ACIDS OR BASES, PREFERABLY SALTS WITH MALEIC ACID; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
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